MalfunctionJQX
BD PHOENIX¿ AP
Received Apr 9, 2026 · Event occurred Mar 10, 2026
Report 1119779-2026-00641 · MDR key 24835756
Device
Generic name
Nephelometer, For Clinical Use
Manufacturer
Becton Dickinson & Co. (sparks)Catalog number
448010
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AP THE USER STATED THAT THE INSTRUMENT WAS CONTAMINATED, CAUSING DISCREPANCIES IN ANTIBIOTIC RESISTANCE AND SENSITIVITY RESULTS ON THE DOWNSTREAM INSTRUMENT. THE AP CONSUMABLES HAVE BEEN CHANGED AND DOWNSTREAM RESULTS WERE IMPROVED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Additional Manufacturer Narrative
H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.